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Atorvastatin Calcium is an antilipidemic drug which is listed in Thai National List of Essential Medicines. In the fiscal year 2019, the Bureau of Drug and Narcotic performed the quality assurance of Atorvastatin Calcium Tablets in accordance with the United States Pharmacopeia (USP 41). The method was verified prior to sample testing. A total of 55 samples with strengths of 10, 20, 40 and 80 mg were collected from public hospitals and manufacturers which consisted of 1 registration number from 1 local manufacturer and 11 registration numbers from 2 overseas manufacturers. All samples presented satisfactory results which complied with pharmacopeial specifications by performing assay, uniformity of dosage unit, organic impuritiies and dissolution. The results indicated that Atorvastatin Calcium Tablets marketed in Thailand obtained satisfactory pharmaceutical characteristics.

Keywords: atorvastatin calcium tablets, quality